Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1021511725 | 10215117 | 25 | F | 201309 | 20160727 | 20140603 | 20160805 | EXP | CA-ABBVIE-14P-028-1230114-00 | ABBVIE | 56.94 | YR | F | Y | 0.00000 | 20160805 | MD | COUNTRY NOT SPECIFIED | CA |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1021511725 | 10215117 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6040687,6040688,6041043,6042179,604 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 1021511725 | 10215117 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 6040687,6040688,6041043,6042179,604 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | |||||||||
| 1021511725 | 10215117 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 1021511725 | 10215117 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 | 7.5 | MG | |||||||
| 1021511725 | 10215117 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 | 7 | MG | |||||||
| 1021511725 | 10215117 | 6 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | 25 | MG | |||||||||
| 1021511725 | 10215117 | 7 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | 12.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1021511725 | 10215117 | 1 | Uveitis |
| 1021511725 | 10215117 | 3 | Eye inflammation |
| 1021511725 | 10215117 | 4 | Therapy change |
| 1021511725 | 10215117 | 5 | Rash |
| 1021511725 | 10215117 | 6 | Blood pressure measurement |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1021511725 | 10215117 | OT |
| 1021511725 | 10215117 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1021511725 | 10215117 | Atelectasis | |
| 1021511725 | 10215117 | Back pain | |
| 1021511725 | 10215117 | Blood creatinine increased | |
| 1021511725 | 10215117 | Blood magnesium decreased | |
| 1021511725 | 10215117 | Cancer pain | |
| 1021511725 | 10215117 | Chromaturia | |
| 1021511725 | 10215117 | Dizziness postural | |
| 1021511725 | 10215117 | Eye inflammation | |
| 1021511725 | 10215117 | Fall | |
| 1021511725 | 10215117 | Fatigue | |
| 1021511725 | 10215117 | Haemoglobin decreased | |
| 1021511725 | 10215117 | Hypotension | |
| 1021511725 | 10215117 | Impaired healing | |
| 1021511725 | 10215117 | Laboratory test abnormal | |
| 1021511725 | 10215117 | Local swelling | |
| 1021511725 | 10215117 | Malaise | |
| 1021511725 | 10215117 | Nodule | |
| 1021511725 | 10215117 | Oedema | |
| 1021511725 | 10215117 | Orthostatic hypotension | |
| 1021511725 | 10215117 | Pain | |
| 1021511725 | 10215117 | Pain in extremity | |
| 1021511725 | 10215117 | Pneumonia | |
| 1021511725 | 10215117 | Pyrexia | |
| 1021511725 | 10215117 | Rash erythematous | |
| 1021511725 | 10215117 | Rash macular | |
| 1021511725 | 10215117 | Renal failure | |
| 1021511725 | 10215117 | Renal function test abnormal | |
| 1021511725 | 10215117 | Renal impairment | |
| 1021511725 | 10215117 | Sarcoidosis | |
| 1021511725 | 10215117 | Skin lesion | |
| 1021511725 | 10215117 | Squamous cell carcinoma of skin | |
| 1021511725 | 10215117 | Tenderness |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 1021511725 | 10215117 | 1 | 20130926 | 2015 | 0 | |
| 1021511725 | 10215117 | 4 | 201309 | 0 | ||
| 1021511725 | 10215117 | 6 | 2014 | 0 | ||
| 1021511725 | 10215117 | 7 | 2014 | 0 |